# ABATON IND · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For ABATON IND · 89-08 · KOREA (THE REPUBLIC OF), import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is KOREA (THE REPUBLIC OF); product is Abaton Far Infrared Massage Bed II Models (800 DX; MS and 800 SA); product code is 89 I - - LY Lamp, infrared, therapeutic heating; date published is 07/13/2011; address is Seojung-Dong , Pyungtaek City, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** ABATON IND _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** Seojung-Dong , Pyungtaek City, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 07/13/2011 _(verified: appears in the quote below)_
- **Product code:** 89 I - - LY Lamp, infrared, therapeutic heating _(verified: appears in the quote below)_
- **Product:** Abaton Far Infrared Massage Bed II Models (800 DX; MS and 800 SA) _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> ABATON IND Date Published : 07/13/2011 Seojung-Dong , Pyungtaek City, KOREA (THE REPUBLIC OF) 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 07/13/2011 Desc: Abaton Far Infrared Massage Bed II Models (800 DX; MS and 800 SA) Notes: Class II

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).